Placental Cord Drainage After Vaginal Delivery

Placental Cord Drainage After Vaginal Delivery: A Randomized Clinical Trial

Placental Cord Drainage after Vaginal Delivery A randomized clinical trial

Study Overview

• Status: Completed
• Conditions: Blood Loss
• Intervention / Treatment: Other: Cord drainage; Other: Cord clamping

• Study Type: Interventional
• Enrollment (Actual): 600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain shams university maternity hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Singleton pregnancy.
• Pregnancy with vertex presentation.
• Gestational age37 up to 42 weeks
• Patient expected to have spontaneous vaginal delivery.
• Maternal age 18 years old or more.

Exclusion Criteria:

• Previous history of Postpartum hemorrhage.
• Antepartum hemorrhage
• Multiple pregnancies
• Instrumental deliveries
• Coagulation disorders
• Over distended uterus (hydramnios, large fetus).
• Patient with extensive extended vaginal or cervical tear.
• Rupture uterus.
• Secondary arrest of cervical dilatation.
• Persistent occipito-posterior.
• Deep transverse arrest of fetal head.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cord drainage	Other: Cord drainage; Cord drainage
Active Comparator: Cord clamping	Other: Cord clamping; Cord clamping

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
blood loss	1 hour

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Actual): November 10, 2018
• Study Completion (Actual): November 10, 2018

Study Registration Dates

• First Submitted: March 24, 2018
• First Submitted That Met QC Criteria: April 2, 2018
• First Posted (Actual): April 4, 2018

Study Record Updates

• Last Update Posted (Actual): January 29, 2019
• Last Update Submitted That Met QC Criteria: January 26, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: AS1751

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No